LDF · Class II · 21 CFR 870.3680

FDA Product Code LDF: Electrode, Pacemaker, Temporary

Temporary pacemakers provide immediate cardiac pacing during hemodynamic emergencies. FDA product code LDF covers temporary pacemaker electrodes used for short-term cardiac stimulation.

These catheters are placed transvenously or epicardially to deliver electrical impulses to the myocardium for temporary rate support during symptomatic bradycardia, post-cardiac surgery, and as a bridge to permanent pacemaker implantation.

LDF devices are Class II medical devices, regulated under 21 CFR 870.3680 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Medtronic Vascular, C.R. Bard, Inc. and Electro-Catheter Corp..

129
Total
129
Cleared
134d
Avg days
1978
Since
129 devices
73–96 of 129
Cleared Dec 23, 1987
WIRE DRESSING
K874310
Slocum and Neal, Inc.
Cardiovascular · 64d
Cleared Dec 03, 1987
TEMPORARY PACEMAKER ELECTRODE
K872972
Oscor Medical Corp.
Cardiovascular · 127d
Cleared Nov 03, 1987
DEKNATEL TEMPORARY CARDIAC PACING WIRE
K873728
Deknatel, Inc.
Cardiovascular · 48d
Cleared Oct 07, 1987
SUTURELESS TEMPORARY EPICARDIAL PACING LEAD
K873474
Symbion, Inc.
Cardiovascular · 37d
Cleared Oct 02, 1987
ADULT WALKING HEEL PRODUCT NO. 4183-130
K873716
Martin Medical
Cardiovascular · 17d
Cleared Sep 25, 1987
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K862970
Medtronic Vascular
Cardiovascular · 415d
Cleared Mar 06, 1987
V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540
K864507
Spectramed, Inc.
Cardiovascular · 112d
Cleared Jun 27, 1986
TB SERIES BIPOLAR PACING LEADS
K861403
Oscor Medical Corp.
Cardiovascular · 73d
Cleared May 05, 1986
SYNCARE TEMPORARY CARDIAC PACING WIRE
K861409
Gyneco, Inc.
Cardiovascular · 20d
Cleared Feb 26, 1986
FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT
K855139
Davis & Geck, Inc.
Cardiovascular · 65d
Cleared Oct 11, 1985
MEDTRONIC MODEL 6405
K853818
Medtronic Vascular
Cardiovascular · 29d
Cleared Sep 16, 1985
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
K851913
Cordis Corp.
Cardiovascular · 138d
Cleared Sep 16, 1985
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
K852513
C.R. Bard, Inc.
Cardiovascular · 96d
Cleared Sep 16, 1985
HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE
K852797
Mansfield Scientific, Inc.
Cardiovascular · 80d
Cleared Aug 29, 1985
NUMED TEMP. STYLET PACING PAROBE 1318694
K851845
NuMED, Inc.
Cardiovascular · 125d
Cleared Apr 19, 1985
NUMED BALLOON PACING CATHETER
K851246
NuMED, Inc.
Cardiovascular · 25d
Cleared Apr 10, 1985
OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR
K850622
Oscor Medical Corp.
Cardiovascular · 50d
Cleared Mar 27, 1985
ELECATH OPEN TIP BIPOLAR PACING CATHETER
K850324
Electro-Catheter Corp.
Cardiovascular · 58d
Cleared Jan 14, 1985
NUMED BALLOON PACING CATHETER
K843290
NuMED, Inc.
Cardiovascular · 146d
Cleared Dec 27, 1984
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
K844003
Electro-Catheter Corp.
Cardiovascular · 76d
Cleared Oct 18, 1984
ELECTRODE CATHETER, ORTHOGONAL TYPE
K841802
Webster Laboratories, Inc.
Cardiovascular · 170d
Cleared Sep 04, 1984
CRITIKON HEPARIN-COATED CARDIOVASCULAR
K843141
Critikon Company, LLC
Cardiovascular · 26d
Cleared Apr 24, 1984
LUMELEC ELECTRODE CATHETER
K834416
Cordis Corp.
Cardiovascular · 131d
Cleared Feb 04, 1984
ELECATH HEPARIN COATED TEMP. PACING
K840109
Electro-Catheter Corp.
Cardiovascular · 25d